Treatment of Antenatal Chlamydia Infection
Information source: Obafemi Awolowo University Teaching Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chlamydia Trachomatis Infection in Pregnancy
Intervention: Amoxicillin (Drug); Erythromycin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Obafemi Awolowo University Teaching Hospital Official(s) and/or principal investigator(s): Temitope O Okunola, MB;BS, Principal Investigator, Affiliation: Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife
Summary
PREGNANT WOMEN IN ANTENATAL CLINIC WILL BE SCREENED FOR CHLAMYDIA TRACHOMATIS INFECTION WITH
ENDOCERVICAL SWAB. THOSE THAT TEST POSITIVE AND SATISFY THE INCLUSION CRITERIA WILL BE
COUNSELLED AND ENROLLED INTO THE STUDY AFTER OBTAINING INFORMED CONSENT. THE PARTICIPANTS
WILL BE RANDOMISED INTO ONE OF THE TWO GROUPS. THE DRUGS WILL BE TAKEN FOR I WEEK AND THE
SEXUAL PARTNER(S) WILL ALSO BE TREATED WITH DOXYCYCLINE FOR 1 WEEK. BARRIER CONTRACEPTION
WILL ALSO BE USED DURING THE TREATMENT. THE SEXUAL PARTNERS WILL BE CONTACTED THROUGH
TELEPHONE CALLS AND THE BENEFITS OF PARTICIPATING IN THE STUDY WILL BE EXPLAINED TO THEM.
LATEX MALE CONDOM WILL BE GIVEN TO THE WOMEN. ALSO, FOLLOW-UP TELEPHONE CALLS WILL BE PUT
ACROSS TO THEM DURING THE TREATMENT WEEK TO ENHANCE COMPLIANCE. A REPEAT ENDOCERVICAL SWAB
WILL BE TAKEN 4 WEEKS AFTER TREATMENT TO CHECK FOR MICROBIOLOGICAL CLEARANCE. A STUDY
PROFORMA WILL BE FILLED DURING THIS VISIT. THE DATA WILL BE ANALYSED USING STATISTICAL
PACKAGE FOR SOCIAL SCIENCES VERSION 17.
Clinical Details
Official title: Erythromycin Versus Amoxicillin for Treatment of Antenatal Chlamydia Trachomatis Infection: A Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: completion of course of medication and microbiological clearance
Secondary outcome: drug discontinuation rates
Detailed description:
AIM(S) OF THE RESEARCH TO ASSESS THE EFFICACY AND TOLERABILITY OF AMOXICILLIN COMPARED TO
ERYTHROMYCIN IN TREATMENT OF ANTENATAL CHLAMYDIA INFECTION
OBJECTIVES OF THE RESEARCH
- TO DETERMINE THE PREVALENCE OF CHLAMYDIA TRACHOMATIS INFECTION IN PREGNANCY
- TO COMPARE THE PROPORTION OF SUBJECTS WITH CLEARANCE OF ANTENATAL CHLAMYDIA TRACHOMATIS
INFECTION BETWEEN THE ERYTHROMYCIN AND AMOXICILLIN GROUPS
- TO COMPARE THE OCCURENCE OF SIDE EFFECTS BETWEEN THE TWO GROUPS
- TO COMPARE THE DRUG DISCONTINUATION RATES BETWEEN THE TWO GROUP
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Test positive to Chlamydia rapid screening kit
2. Estimated gestational age less than 36 weeks
3. Consent to participate in the study
4. Willingness or ability to comply with follow-up schedule
Exclusion Criteria:
1. Antenatal patients whose gestational age is more than 36 weeks
2. History of reaction to any of the drugs
3. Women with low lying placenta or placenta Praevia
4. History of other antibiotics intake within two weeks of recruitment
Locations and Contacts
Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Ile Ife, Imesi Ile 220001, Nigeria
Additional Information
Related publications: Alary M, Joly JR, Moutquin JM, Mondor M, Boucher M, Fortier A, Pinault JJ, Paris G, Carrier S, Chamberland H, et al. Randomised comparison of amoxycillin and erythromycin in treatment of genital chlamydial infection in pregnancy. Lancet. 1994 Nov 26;344(8935):1461-5.
Starting date: October 2013
Last updated: March 26, 2014
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